| Primary Device ID | 30810087350254 |
| NIH Device Record Key | e338ef51-155c-4292-a924-a1b9aa857521 |
| Commercial Distribution Discontinuation | 2023-01-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Coulmed |
| Version Model Number | DI-5934-706 |
| Catalog Number | DI-5934-706 |
| Company DUNS | 047115479 |
| Company Name | Coulmed Products Group LLC |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810087350246 [Unit of Use] |
| GS1 | 10810087350250 [Primary] |
| GS1 | 30810087350254 [Package] Contains: 10810087350250 Package: Case [1000 Units] Discontinued: 2023-01-06 Not in Commercial Distribution |
| FYF | CAP, SURGICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-07-17 |
| Device Publish Date | 2023-01-06 |
| 10810087355965 | Gel Pediatric Chest Roll, Flat Bottom Surface, 3"W x 10"L x 3"T |
| 10810087355989 | Replacement Pad for Skytron 3501B Surgical Table; Body Section Only; 2" thich, Tier II Pressure |
| 10810087355972 | Replacement Pads for Skytron 3501B Surgical Table; 3 Piece Set; 2" thick, Tier II Pressure Relie |
| 10810087356047 | Replacement Pad for MIDMARK 7100 Surgical Table, Leg/Foot Section Only, 2" thick, Standard Foam, |
| 10810087356030 | Replacement Pad for MIDMARK 7100 Surgical Table, Head Section Only, 2" thick, Standard Foam, Bla |
| 30810087350476 | Universal Sterile Mayo Stand Drape/Cover: 23" x 54" |
| 30810087350469 | Sterile 3/4 Drape/Sheet: 57" x 63" |
| 30810087350452 | Covex Heavy Duty Sterile Drape for OR Specific Two Tier Back Table: One Piece Construction, 6' L |
| 30810087350445 | Covex Heavy Duty Sterile Drape for OR Specific Two Tier Back Table: One Piece Construction, 5' L |
| 30810087350438 | Covex Heavy Duty Sterile Drape for OR Specific Two Tier Back Table: One Piece Construction, 4' L |
| 30810087350421 | Covex Custom Sterile Drape for Two Tier Tables with 8" Back, One Piece Construction, 72"Long |
| 30810087350414 | Covex Heavy Duty Sterile Drape for Two Tier Back Table: One Piece Construction, 72"Long |
| 30810087350407 | 60" Wide Custom Double Back Table Cover |
| 30810087350391 | Covex Heavy Duty Sterile Drape for Two Tier Back Table: One Piece Construction, 60"Long |
| 30810087350384 | Covex Heavy Duty Sterile Drape for Two Tier Back Table: One Piece Construction, 49"Long |
| 30810087350377 | Covex Sterile Camera Drape with Blue Elasticized Tip: 7" x 96" |
| 30810087350360 | Covex Sterile Probe Cover with Gel: 5" x 96" inch |
| 30810087350353 | Premium Chemotherapy Gown, Perforated Back, Thumb Holes, Blue Polyethylene |
| 30810087350346 | Standard Sterile Surgical Gown, with Towel, XX-Large, AAMI 4 |
| 30810087350339 | Standard Sterile Surgical Gown, with Towel, X-Large, AAMI 4 |
| 30810087350322 | Standard Sterile Surgical Gown, with Towel, Large, AAMI 4 |
| 30810087350315 | Standard Sterile Surgical Gown, Poly Reinforced, XX-Large, AAMI 3 |
| 30810087350308 | Standard Sterile Surgical Gown, Poly Reinforced, X-Large, AAMI 3 |
| 30810087350292 | Standard Sterile Surgical Gown, Poly Reinforced, Large, AAMI 3 |
| 30810087350285 | Standard Sterile Surgical Gown, XX-Large, AAMI 3 |
| 30810087350278 | Standard Sterile Surgical Gown, X-Large, AAMI 3 |
| 30810087350261 | Standard Sterile Surgical Gown, Large, AAMI 3 |
| 30810087350254 | Round SMS Bouffant Cap 27" |
| 30810087350230 | Bouffant Caps, 24", Blue Polypropylene, Latex free |
| 30810087350223 | Pleated SMS Bouffant Caps, 24", White Polypropylene, Latex free |
| 30810087350216 | Pleated Bouffant Caps, 21", Blue Polypropylene, Latex free, Double Elastic Band |
| 30810087350209 | Pleated SMS Bouffant Caps, 21", White Polypropylene, Latex free, Double Elastic Band |
| 30810087350179 | Heavy-Duty SMS Shoe Covers with Skid-Resistant Tread |
| 10810087351073 | Mayo Stand Cover, 21" X 18-1/2" X 5/8" |
| 30810087350162 | Covex Sterile Microscope Drape for Leica: 54" x 150" (137cm x 381cm) |
| 30810087350155 | Covex Sterile Microscope Drape for Leica: 54" x 120" (137cm x 305cm) |
| 30810087350148 | Covex Sterile Microscope Drape for Leica: 46" x 120" |
| 30810087350131 | Covex Sterile Microscope Drape for Zeiss MD: 46" x 120" (117cm x 305cm) |
| 30810087350124 | Covex Sterile Microscope Drape for Zeiss MD: 54" x 150" |
| 30810087350117 | Covex Sterile Microscope Drape for Zeiss MD: 46" x 105" |
| 30810087350100 | Covex Sterile X-Ray Cassette Cover: 24" x 24" |
| 30810087350094 | Covex Sterile C-Arm Cover Kit fitted for OEC Elite, 9900, 9800, 9600, and Brivo C-Arm's. Include |
| 30810087350087 | Covex Sterile C-Arm Drape with Tape/Bands: 41" x 74" |
| 30810087350070 | Covex Sterile C-Arm Drape with Elastic Bands: 41" x 74" |
| 30810087350063 | Covex Sterile C-Arm Cover: 41" x 74" |
| 30810087350056 | Covex Sterile Dome Cover: 27" Polyethylene Bag with Elastic Band |
| 30810087350049 | Covex Sterile C-Arm Cover: Half Bag with Latex-Free Band, 36"W x 80"L |
| 30810087350032 | Covex Sterile C-Arm Cover fitted for Fluoroscan Mini C-Arm, With Elastic Opening, 54" x 78" |
| 30810087350025 | Foot Switch Cover, Disposable, 17" X 15" |
| 30810087350018 | Covex Sterile Mini C-Arm Cover fitted for OrthoScan C-Arm, Keyboard, and Monitor Handles |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COULMED 76230706 2737954 Live/Registered |
MACDOUGALL, MICHAEL, MR. 2001-03-26 |